| CTRI Number |
CTRI/2025/09/094737 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using ultrasound versus the traditional feel-by-hand method to give epidural injections in elderly patients. |
|
Scientific Title of Study
|
Preprocedural ultrasonography versus landmark guided technique for lumbar epidural anaesthesia in geriatric patients : a randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sahanaa S |
| Designation |
Postgraduate |
| Affiliation |
Sri Manakula Vinayagar Medical College And Hospital |
| Address |
Room no.109, Department of Anesthesiology, Sri Manakula Vinayagar medical college and hospital, Kalitheerthalkuppam, Puducherry.
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9751209955 |
| Fax |
|
| Email |
sahanaa5995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagalakshmi |
| Designation |
Professor |
| Affiliation |
Sri Manakula Vinayagar Medial College And Hospital |
| Address |
Room no. 105, Department of Anesthesiology, Sri manakula vinayagar medical college and hospital, Kalitheerthalkuppam, Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9894510137 |
| Fax |
|
| Email |
vedha83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sahanaa S |
| Designation |
Postgraduate |
| Affiliation |
Sri Manakula Vinayagar Medical College And Hospital |
| Address |
Room no.109, Department of Anesthesiology, Sri Manakula Vinayagar medical college and hospital, Kalitheerthalkuppam, Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9751209955 |
| Fax |
|
| Email |
sahanaa5995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula Vinayagar Medical College And Hospital, Kalitheerthalkuppam, Puducherry 605107 |
|
|
Primary Sponsor
|
| Name |
Dr Sahanaa S |
| Address |
Room no. 109, Department of Anesthesiology, Sri manakula vinayagar medical college and hospital, Kalitheerthalkuppam, Puducherry 605107 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sahanaa S |
Sri Manakula Vinayagar Medical College And Hospital |
Room no, 109, Department of Anaesthesia, Kalitheerthalkuppam, Puducherry- 605107
Pondicherry
PONDICHERRY |
9751209955
sahanaa5995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH- ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
by traditional palpatory method |
To mark the epidural needle insertion point by palpatory technique in posted patients |
| Intervention |
Ultrasonography machine |
To mark the insertion point in the spine using ultrasound machine before epidural needle placement in selected patients |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
- Age 60 to 80 years
- Patients of either gender
- Scheduled for elective lower abdominal and lower limb surgeries.
- ASA PS 1 to 3 |
|
| ExclusionCriteria |
| Details |
- Uncooperative or cognitively impaired patients
- Known allergic to local anesthetics
- Active infection in intervention area
- Known contraindication to central neuraxial blockade |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure and compare the time required for successful epidural needle placement by loss of resistance method using preprocedural ultrasonography versus the landmark guided technique in geriatric patients scheduled for lower abdominal and lower limb surgeries. |
at baseline, 2, 4, 6 and 8 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- To compare the number of needle attempts and needle redirections taken to reach the epidural space between the two groups
- To compare the incidence of complications following epidural catheter placement |
0 min, 2 hour, 4 hour, 6 hour , 8 hour |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/10/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - sahanaa5995@gmail.com
- For how long will this data be available start date provided 30-12-2026 and end date provided 18-12-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study will be conducted in Department of Anesthesiology of Sri Manakula Vinayagar Medical College
and Hospital, a tertiary hospital in South India. The study design is a Randomized controlled trial. Patients
who meet the inclusion criteria will be included in the study. All the eligible participants will be explained
about the nature of the study and procedure. A written informed consent will be taken from them. After
obtaining informed consent, pre-anesthetic assessment will be carried out for all participants on the day before
surgery. All patients will be premedicated with T.Pantoprazole 40 mg orally on the night before surgery. All
participants will be kept nil per oral with 6 hours for solids and 2 hours for liquids before the day of surgery.
Patient’s demographic data like age, sex, height, weight, BMI will be recorded.
On the day of surgery, patients in both groups are taken to the operating room and underwent standard
monitoring like ECG, pulse oximetry, NIBP, and intravenous access is established.
In Group B, epidural analgesia is performed using the conventional surface anatomic landmark guided
technique. With the patients in sitting position, a line joining the two iliac crests (Tuffier’s line) is palpated
and used to determine the vertebral level of L4. And the most appropriate entry site is determined by palpating
the spinous process and marked. The landmark identification is confirmed by the attending anesthesiologist
and was graded according to the palpation difficulty score as 0, 1, 2 and 3.8
Score 0: Spinous processes can be palpated, and the interspinous spaces are evident.
Score 1: Spinous processes can be palpated, and interspinous spaces are not evident.
Score 2: Spinous processes cannot be palpated, interspinous spaces arenot evident, and vertebral column can
be palpated on the midline or outside the midline,
Score 3: Spinous processes cannot be palpated, interspinous spaces are not evident, and vertebral column
cannot be palpated.
After ensuring sterile conditions, epidural catheter is placed at the marked point using an 18-gauge Tuohy’s
needle.
In group A, epidural analgesia is performed using the ultrasound guided technique. A curved array low
frequency (3-5 MHz) is used for systematic screening of the spine. The ultrasonography is performed in the
9
sitting position for the epidural needle placement. Ultrasound imaging of the lumbar spine is
performed by the trained anesthesiologist. And the following points are obtained during pre-procedural
ultrasound scanning,
• The interspace level.
• The midline of the spine.
• The puncture point.
• The angle of needle insertion.
• The depth to the epidural space.
The probe is placed longitudinally along the spine parallel to it, 2-3 cm lateral to the midline, at the level of
sacrum and directing it towards the center of the spinal canal. With this paramedian longitudinal view,
multiple levels can be visualized in one scanned image. The sono-anatomical structures that can be seen in
this plane include,
1) sacrum
2) lamina
3) ligamentum flavum and dorsal dura mater- Anterior complex.
4) ventral dura mater, posterior longitudinal ligament and vertebral body – Posterior complex.
Then the ultrasound transducer is moved cephalad using the sacral level as a starting point. The upper border
of the sacrum can be identified as a hyperechoic flat reflective surface on the ultrasound image
at about 3–5 cm under the skin. As the transducer is advanced cephalad, the interspace can be identified as an
indentation of the reflective surface, followed by a ‘‘saw-tooth’’ pattern representing the lamina interrupted
by interspaces. Each interspace consists of two parallel hyperechoic bands (equal sign), with the anterior
complex as the outer band and the posterior complex as the deeper one. The desired interspinous level is
identified by counting the alternating laminae and the corresponding interspaces. The midpoint of the
interspace is determined by centering a particular interspace on the screen. With the transducer kept still, a
line is drawn in the skin at the center of lateral aspects of the transducer. Then the transducer is placed
horizontally in the same site centering the interarticular joint in the screen, a vertical line is drawn from the
center of upper aspect of the transducer. The transducer is then removed, and lines are drawn to connect these
marks. The insertion point is determined by the intersection of these two lines.
10
The angle at which the anterior and posterior complex were best visualized is considered as the optimal angle
for needle insertion. The angle of insertion will be measured using a smartphone based digital protractor app.
After ensuring sterile conditions, epidural catheter is secured at the intersection point using a 18-gauge
Tuohy’s needle.
The primary outcome in this study is to calculate and compare the total procedure time required for epidural
needle placement in both the groups. The total procedure time is defined as, the time taken from the start of
epidural needle contact with the skin to successful placement of the epidural needle, which is confirmed by a
feel of sudden loss of resistance as the needle enters the epidural space. Followed by advancement of catheter
smoothly without resistance, with free flow of test dose through the catheter, with stable hemodynamic status
after giving test dose indicates successful epidural catheter placement.In addition to this, the number of needle insertion attempts (Number of times the needle is inserted through
the skin), number of needle redirections (Number of times needle is redirected without withdrawing fully)
and complications like accidental dural puncture, vascular puncture following epidural catheter placement is
assessed. Epidural analgesic effect is also assessed, after extubating in case of combined epidural with general
anesthesia and after weaning off of spinal anesthetic drug effect in case of combined spinal – epidural
anesthesia using Visual analog score ranging between 1 to 10. Patients will be shifted to post operative ward.
Postoperative epidural analgesic effect is assessed at 2-hour, 4-hour, 6-hour and 8-hour. All data obtained in
the study were analyzed and recorded by an independent observer. |